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PEG FULLY THREADED, LOCKING recallZ-2965-2018 · Zimmer Biomet, Inc. · initiated Jul 12, 2018

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A size 22mm threaded peg was found in the package of a 10mm unit.

FDA root cause category: Under Investigation by firm

What the company is doing

The firm, Zimmer Biomet, sent an "Urgent Medical Device Recall " letter dated 7/12/18, to customers. The described the product, problem and actions to be taken.The letter instructed Risk Managers to perform the following actions: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]. Distributors were instructed to perform the following: Your Responsibilities Review this notification and ensure that affected team members are aware of the contents. 1. Immediately locate and quarantine affected product in your inventory. 2. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. Request a Return Authorization Number through [email protected] for international returns c. For each return, send a copy of Att

Recall details

Recall number
Z-2965-2018
Status
Terminated
Initiated by the company
Jul 12, 2018
Recalling firm
Zimmer Biomet, Inc.
Quantity
25 units
Product code
HRS
FDA submissions
K081546
Distribution
International Distribution to countries of: Japan and Netherlands.

Product description

Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

Code information (models, lots, serial numbers)

Lot 969440; UDI (01)00887868012310(17)280309(10)969440

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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